Little Evidence for Nondrug Tx for ADHD

Action Points

Note that this series of meta-analyses failed to demonstrate that nonpharmacologic interventions for ADHD are clearly beneficial, particularly when assessments were performed in blinded fashion.

Be aware that the trials included suffered from a high degree of heterogeneity, limiting the ability to interpret the summarized results.

Nondrug treatments for attention deficit/hyperactivity disorder have limited evidence of efficacy and their use for core symptoms is not supported, a European guideline committee concluded.

Uncontrolled clinical evaluations produced positive results for a variety of dietary and psychological interventions. However, the significant benefits disappeared in "probably blinded" assessments, except for free fatty acid (FFA) supplementation and avoidance of artificial food color, according to an article from the European ADHD Guideline Group published online in the American Journal of Psychiatry.

"Better evidence for efficacy from blinded assessments is required for behavioral interventions, neurofeedback, cognitive training, and restricted-elimination diets before they can be supported as treatments for core ADHD symptoms," Edmund J.S. Sonuga-Barke, PhD, of the University of Southampton in England, and co-authors wrote in conclusion.

Although multimodal clinical strategies are recommended for ADHD, drug therapy has proven efficacious and is widely used as the primary treatment for core symptoms. However, ADHD medications have a number of potential limitations including inability to normalize the condition in most patients, uncertain long-term effectiveness, adverse effects, and clinician and parent reservations about use, the researchers noted.

Meta-analyses and systematic reviews have supported the efficacy of nonpharmacologic interventions in ADHD, but inclusion of nonrandomized trials and non-ADHD patients and outcome measures has complicated attempts to evaluate the interventions' effects on ADHD core symptoms, the committee members wrote.

To address the limitations of existing evidence, the guideline committee performed six meta-analyses limited to randomized trials of dietary and psychological treatments for ADHD. Their primary objective was to survey the evidence as a prelude to development of clinical guidelines for ADHD.

The investigators searched multiple literature databases to identify all randomized clinical trials (including crossover trials) published since the databases' inception. The primary outcome of interest was the change in total ADHD symptom score from baseline to the first assessment after initiation of the intervention.

The literature review yielded 54 published trials with adequate statistical information -- 15 studies of behavioral interventions, 11 of FFA supplementation, eight each of neurofeedback and exclusion of artificial food color, seven of restrictive-elimination diets, and six of cognitive training.

The trials of dietary interventions received a grade of 3 (fair) for overall quality. Collectively, the trials had a standard mean difference (SMD) of 1.48 in meta-analyses of six domains, using the most proximal assessment. Most of the studies showed large, statistically significant effects favoring the intervention. Analysis of "probably blinded assessments" reduced effect size such that all fell short of statistical significance.

The dietary intervention studies exhibited significant heterogeneity (P<0.00001), and inclusion of drug therapy in most of the trials precluded sensitivity analysis.

The trials of artificial food color exclusion yielded statistically significant differences favoring the intervention in both the most proximal and probably blinded assessments. Limiting the analysis to four trials with low/no medication use lowered the SMD to 0.32 (95% CI 0.13 to 0.77).

The trials of FFA supplements consisted of five that involved omega-3, two of omega-6, and four that evaluated both types of supplements. The trials produced an SMD of 0.21, which decreased to 0.17 in an analysis limited to nine trials involving patients with low/no medication use (95% CI 0.01 to 0.34).

The psychological interventions (cognitive training, neurofeedback, and behavioral interventions) yielded significant symptomatic improvement in the most proximal assessments but not in the probably-blinded assessments. Limiting their analysis to trials of low/no medication use did not change the overall results.

"Dietary interventions had small beneficial effects on ADHD symptoms," the authors wrote in their summary of the findings. "Evidence supporting psychological interventions was strongly influenced by whether the analysis was for the most proximal or probably-blinded assessments. Nonpharmacological standardized mean differences were substantially smaller than those reported for ADHD medications."

The European ADHD Guidelines Group received support for meetings and analyses from Brain Products GMBH, Janssen-Cilag, Lilly, Medice, Shire, and Vifor.

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